Eli Lilly Canada Inc. v. Apotex Inc., 2015 FC 875 (Gleason, J.)
July 20, 2015
Jamie Mills, Chantal Saunders and Beverley Moore of Borden Ladner Gervais, LLP for the Applicant Eli Lilly Canada Inc. and Respondent Patentee ICOS Corporation
Andrew Brodkin, Jordan Scopa and Sandon Shogilev of Goodmans LLP for the Respondents Apotex Inc.
Lilly brought an application for an order under section 6 of the PMNOC Regulations to prohibit the Minister from issuing an NOC to Apotex for approval to sell its generic version of tadalafil until after the expiry of the Canadian Patent 2,226,784 on July 11, 2016.
Tadalafil is used to treat male erectile dysfunction (or ED). Lilly markets tadalafil under the brand name CIALIS.
This is the second PMNOC case involving the 784 Patent. On January 7, 2015, Justice Yves de Montigny issued reasons in Eli Lilly Canada v Mylan Pharmaceuticals ULC, 2015 FC 17, 249 ACWS (3d) 191 [Mylan Tadalafil] in which he dismissed Mylan’s prohibition application because he found Mylan’s allegations of invalidity to be unjustified. Some of the arguments advanced by Apotex in this case are similar to those advanced by Mylan in Mylan Tadalafil and some of the evidence in the two cases is similar.
Justice Gleason reached the same conclusion as Justice de Montigny - that Apotex’ allegations of invalidity are unjustified. Justice Gleason also found Apotex’ argument regarding Lilly’s alleged lack of standing to be without merit.
Three issues are addressed in the decision:
- Is the 784 Patent invalid for double patenting over the 377 Patent (an earlier Lilly Patent for the compound)?
- Is the 784 Patent invalid for insufficiency?
- Does Lilly lack standing to bring this application due to a defect in the chain of title?
Lilly was successful on all issues.
Double Patenting
In order to assess a claim of double patenting, the Court must undertake the following three-step inquiry:
- Determine what is claimed in each of the patents, construing the claims, if necessary;
- Determine if the claims in the two patents are identical. If they are, and the same invention is claimed, the second patent will be void for same invention or coterminous double patenting; and
- If the inventions claimed in the two patents are not identical, the Court must then go on to determine if the invention claimed in the later patent is inventive or patentably distinct from the invention claimed in the earlier patent. If not, then the second patent will be void for obviousness-type double patenting.
There was a dispute over which date should be used for the obviousness-type double patenting.
The possible dates were set out in the following chart:
- January 21, 1994 - Priority date - '377 Patent
- December 22, 1994 - Publication date - '902 Application
- January 19, 1995 - Canadian filing date - '377 Patent
- July 14, 1995 - Priority date - '784 Patent
- Jully 27, 1995 - Publication date - '377 Patent
- June 1996 - Boolell Paper
- July 11, 1996 - Canadian filing date - '784 Patent
- February 6, 1997 - Publication date - '784 Patent
In Mylan Tadalafil, Justice de Montigny assessed obviousness-type double patenting at the priority date of the 377 Patent, and, in the alternative, at the priority date of the 784 Patent. In the absence of clear authority, he referred to the purpose of the double patenting doctrine and determined that the appropriate date is the priority date of the first patent.
Applying the doctrine of comity, Justice Gleason used Justice de Montigny’s construction of the 377 and 784 Patents and his finding that the obviousness-type double patenting analysis is to be conducted as of the priority date of the 377 Patent, as starting points for her analysis.
Ultimately, Justice Gleason rejected use of the Canadian filing or publication dates of the 784 Patent for the conduct of the obviousness-type double patenting analysis. Of the only other two dates in contention, the priority date of the 377 Patent and the priority date of the 784 Patent, Justice Gleason’s analysis led to the same result (not obvious), and therefore she refused to make a firm determination as to the correct date to use.
Insufficiency
Justice Gleason found that there is adequate disclosure in the 784 Patent to enable the production of solvates of tadalafil and 3-methyl tadalafil and that, from there, the skilled person, relying on his or her common general knowledge, would be able to create and, if necessary, modify reaction conditions so as to favour hydrate formation. Thus, there was adequate disclosure in the 784 Patent and Apotex’ allegation of insufficiency is therefore not justified.
By: Peter W. Choe, Gowling Lafleur Henderson LLP